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ustekinumab products — Blue Cross Blue Shield of Illinois

active psoriatic arthritis (PsA)

Initial criteria

  • Patient has an FDA labeled indication or an indication supported in compendia for the requested agent and route of administration
  • For psoriatic arthritis (PsA): patient has active PsA AND ONE of the following: (1) tried and had inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months; OR (2) intolerance or hypersensitivity to ONE conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) severe active PsA (e.g., erosive disease, elevated ESR/CRP, long-term damage interfering with function, rapidly progressive); OR (5) concomitant severe psoriasis; OR (6) prior use of another biologic immunomodulator or Otezla for PsA
  • For plaque psoriasis (PS): patient has moderate to severe PS AND ONE of the following: (1) tried and had inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months; OR (2) intolerance or hypersensitivity to ONE conventional agent; OR (3) FDA labeled contraindication to ALL conventional agents; OR (4) severe active PS (>10% BSA, select critical locations, intractable pruritus, serious emotional consequences); OR (5) concomitant severe PsA; OR (6) prior use of another biologic immunomodulator or Otezla for PS
  • For Crohn’s disease (CD): patient has moderately to severely active CD AND ONE of the following: (1) currently stable on requested agent; OR (2) tried and had inadequate response to ONE conventional agent (6‑MP, azathioprine, corticosteroids, methotrexate) after ≥3 months; OR (3) discontinued conventional agent due to lack of efficacy, diminished effect, or adverse event; OR (4) intolerance or hypersensitivity to ONE conventional agent; OR (5) FDA labeled contraindication to ALL conventional agents; OR (6) ONE agent expected ineffective or harmful based on patient characteristics or medical necessity; OR (7) tried another agent in same class discontinued for inefficacy or adverse event; OR (8) prior use of biologic immunomodulator for CD
  • For ulcerative colitis (UC): patient has moderately to severely active UC AND ONE of the following: (1) currently stable on requested agent; OR (2) tried and had inadequate response to ONE conventional agent (6‑MP, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months; OR (3) discontinued conventional agent due to lack of efficacy, diminished effect, or adverse event; OR (4) intolerance or hypersensitivity to ONE conventional agent; OR (5) FDA labeled contraindication to ALL conventional agents; OR (6) ONE agent expected ineffective or harmful based on patient characteristics or medical necessity; OR (7) ONE agent not in best interest based on medical necessity; OR (8) tried another same‑class drug discontinued for inefficacy or adverse event; OR (9) severely active UC; OR (10) prior biologic immunomodulator for UC
  • For any other diagnosis: requested agent is preferred OR if non‑preferred, patient meets one of: (1) stage 4 advanced/metastatic cancer appropriate use; OR (2) currently stable on requested agent; OR (3) tried and inadequate response to THREE preferred agents after ≥6‑month trial each; OR (4) THREE preferred agents discontinued for inefficacy or adverse event; OR (5) intolerance/hypersensitivity to THREE preferred agents; OR (6) contraindication to ALL preferred agents; OR (7) THREE preferred agents expected ineffective or harmful or barrier to care; OR (8) THREE preferred agents not in best interest; OR (9) another same‑class drug discontinued for inefficacy/adverse event
  • If ustekinumab requested for CD or UC: must have received or will receive ustekinumab IV for induction therapy
  • If ustekinumab 90 mg requested: patient has diagnosis of psoriasis with weight >100 kg; OR dual psoriasis and PsA with weight >100 kg; OR diagnosis of CD or UC
  • Prescriber is a specialist in relevant field or has consulted with one
  • Patient will not use requested agent concurrently with another immunomodulator unless combination supported and not limited by labeling
  • Patient does not have FDA labeled contraindications
  • Patient tested for latent TB and if positive has begun therapy

Reauthorization criteria

  • Continuation approved if patient currently stable on requested agent and criteria for ongoing safety (no contraindications, TB treated if positive) are met

Approval duration

12 months